Patients with peri-anal fistula in Crohn’s disease. Crohn's disease of both small and large intestine with fistula
Conditions
Interventions
Intervention 1: Intervention group: patients receive MSC. Each patient will receive 3 injections (1 × 106 cells / Kg) first injection will be locally and then next two administrations intravenously w
Sponsors
Shahid Beheshti University of Medical Sciences
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: Males or females between 18-75 years old with a clinically confirmed diagnosis of Crohn’s disease Medical therapy resistant perianal fistula Mild to moderate Crohn’s disease activity index
Exclusion criteria
Exclusion criteria: Any reasons which reported as side effect of interventions If participants would like to leave the trials for any reasons Active infectious disease Pregnant patient Liver or kidney insufficiency Underlying malignancy Uncontrolled diabetes History of chemoradiotherapy Patients with immunodeficiency Severe Crohn’s disease activity index
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Total number of soft/liquid stools in the last 7 days. Timepoint: Before starting, after 1, 3, 6 months. Method of measurement: Assessment of CDAI (Crohn's disease activity Index).;Flatus. Timepoint: Before starting, after 1, 3, 6 months. Method of measurement: Jorge – Wexner fecal incontinence score.;IL-10. Timepoint: Before starting, after 1, 3, 6 months. Method of measurement: Blood test.;TNFa. Timepoint: Before starting, after 1, 3, 6 months. Method of measurement: Blood test.;Liquid secretion. Timepoint: Before starting, after 1, 3, 6 months. Method of measurement: Jorge – Wexner fecal incontinence score.;Solid secretion. Timepoint: Before starting, after 1, 3, 6 months. Method of measurement: Jorge – Wexner fecal incontinence score.;Pad. Timepoint: Before starting, after 1, 3, 6 months. Method of measurement: Jorge – Wexner fecal incontinence score.;Lifestyle. Timepoint: Before starting, after 1, 3, 6 months. Method of measurement: Jorge – Wexner fecal incontinence score.;Abdominal pain. Timepoint: Before starting, after 1, 3, 6 months. Method of measurement: Assessment of CDAI (Crohn's disease activity Index).;General well-being. Timepoint: Before starting, after 1, 3, 6 months. Method of measurement: Assessment of CDAI (Crohn's disease activity Index).;Anti-diarrhea drug use. Timepoint: Before starting, after 1, 3, 6 months. Method of measurement: Assessment of CDAI (Crohn's disease activity Index).;Abdominal mass. Timepoint: Before starting, after 1, 3, 6 months. Method of measurement: Assessment of CDAI (Crohn's disease activity Index).;Hematocrit. Timepoint: Before starting, after 1, 3, 6 months. Method of measurement: Assessment of CDAI (Crohn's disease activity Index).;Arthritis/arthralgiasIritis/uveitis. Timepoint: Before starting, after 1, 3, 6 months. Method of measurement: Assessment of CDAI (Crohn's disease activity Index).;Erythema nodosum. Timepoint: Before starting, after 1, 3, 6 months. Method of measurement: Assessment of CDAI (Crohn's disease | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactShabnam Shahrokh, Fakhrossadat Anaraki
Shahid Beheshti University of Medical Sciences
Outcome results
None listed